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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS

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DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS Back to Search Results
Model Number 9500-27
Device Problems Use of Device Problem (1670); Invalid Sensing (2293)
Patient Problems Headache (1880); Hypoglycemia (1912); Malaise (2359)
Event Date 06/14/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated effects.
 
Event Description
Patient contacted dexcom on (b)(6) 2016 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter that occurred on (b)(6) 2016. The sensor was inserted on (b)(6) 2016. Patient stated that before she went into her appointment her cgm said she was at 55mg/dl and when she tested she was at 92mg/dl. Patient stated that it was happening often so she would treat according to the dexcom and then it would be way off 30 minutes later. Patient stated that her numbers were shooting up super high and then shooting down super fast to the point where she was feeling miserable: horrible headaches, major forgetfulness, etc. Patient's blood sugars even dropped below 40mg/dl and her dexcom cgm still read above 80mg/dl. Patient felt like her body recognized her symptoms before her dexcom did. No additional event or patient information was provided. No product or data was returned for evaluation. The reported event could not be confirmed. A root cause could not be determined. Treatment decisions were made based on cgm values. The dexcom g5 mobile continuous glucose monitoring system states: the dexcom g5 mobile cgm system does not replace your bg meter. When making treatment decisions, such as the amount of insulin you need, only use your bg value. Don't use the dexcom g5 mobile cgm system sensor glucose readings because readings can be different from your bg value. If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event.
 
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Brand NameDEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Type of DeviceMDS
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key5806662
MDR Text Key49944580
Report Number3004753838-2016-13314
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9500-27
Device Catalogue NumberSTS-GL-011
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/19/2016 Patient Sequence Number: 1
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